Study of Cervix and Inflammation in Preterm Birth Prediction (COLIBRI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jean-Charles Pasquier, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01007513
First received: November 3, 2009
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

Preterm birth rate is 7.2% in Quebec, it's risen worldwide in the past decade and it's the leading cause of perinatal mortality and morbidity. Preterm birth is a major public health problem. Preterm labor leading to preterm birth is difficult to diagnose and prediction of preterm birth is a medical challenge. In the past years, research found that transvaginal ultrasound to assess the cervix of the uterus and vaginal detection of inflammatory protein, specific bacteria and fetal fibronectin can help to detect women at increase risk of preterm delivery. The investigators believe that a combination of these tests can lead to a better prediction of preterm delivery. The investigators want to conduct a study among women judged at increase risk of preterm delivery by their physician (having contractions, modified cervix, past-history of preterm delivery or multiple pregnancy) and assess their cervix by ultrasound and sample their vaginal secretion. The investigators want to analyze the vaginal sampling and look for inflammatory proteins. The objective of this study is to prove the feasibility of this assessment method and elaborate a better predictive test that the investigators can easily use in obstetrics clinics and hospitals.


Condition Intervention
Preterm Birth
Procedure: Transvaginal ultrasound
Procedure: Vaginal secretion sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cervical Assessment by Supracervical, Cervical and Vaginal Markers: Simultaneous Transvaginal Ultrasound and Inflammatory Proteins Detection

Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Preterm birth < 34 gestational weeks among patient with presence of supracervical factor at ultrasound study. [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Presence of inflammatory proteins in vaginal secretion of patient with presence of supracervical factors at transvaginal ultrasound. [ Time Frame: December 2009 ] [ Designated as safety issue: No ]
  • Neonatal morbidity of preterm infant. [ Time Frame: December 2009 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Vaginal secretion


Enrollment: 100
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
At risk patient for preterm delivery
Patient referred to the MFM clinic for a risk evaluation for preterm delivery.
Procedure: Transvaginal ultrasound
A transvaginal ultrasound with an endocavitary probe will be done as required by the medical condition of the patient. The cervical and supracervical factors will be noted.
Procedure: Vaginal secretion sampling
Vaginal secretion swab will be collected each time patient will have a transvaginal ultrasound. The sample will be centrifuged, frozen and store to be analysed at the end of the study with multiplex antibody arrays.
Other Name: Ray Biotech Multiplex Antibody Arrays

Detailed Description:

Preterm birth rate in Quebec is 7.2% and, despite extensive research, the rate of preterm birth has risen worldwide over the past decades. Preterm birth is, all over the world, the first cause of perinatal mortality and morbidity. Spontaneous preterm birth (sPTB) groups premature births with intact and ruptured membranes and represents 70% of preterm delivery. The two conditions associated with sPTB share a common physiopathology and a progressive cascade of events. Extensive evidence supports a central role for the production of prostaglandins, inflammatory cytokines and matrix metalloproteinases (MMP) in the cervix and decidua to promote cervical ripening and decidual and fetal membrane activation but, the exact progression of events remains unclear. Several factors were described as risk factor for sPTB like bacterial vaginosis, inflammatory cytokines and fetal fibronectin in vaginal secretions. The transvaginal ultrasound of the cervix (TVUS), which estimates the length and the aspect of the cervix, can be used as predictive factor of preterm birth. To date, no study has addressed the supra-cervical region by transvaginal ultrasound. This region may be an important key of the inflammatory process leading to sPTB. The assessment of this region by ultrasound can be a predictive marker of sPTB. We want to prove the feasibility of this new approach of sPTB prediction : the transvaginal ultrasound assessment of the supracervical and cervical region associated with detection of vaginal inflammation.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

At risk women referred by their physician to the MFM clinic for evaluation of preterm birth risk.

Criteria

Inclusion Criteria:

  • Live singleton or multiple pregnancy
  • Clinical risk of preterm delivery
  • Pregnancy between 20 and 34 gestational weeks

Exclusion Criteria:

  • Delivery on the day of the ultrasound
  • Major fetal anomaly
  • Previa placentation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007513

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Jean-Charles Pasquier, Md, PhD Centre Hospitalier Universitaire de Sherbrooke
  More Information

No publications provided

Responsible Party: Jean-Charles Pasquier, Dr, Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01007513     History of Changes
Other Study ID Numbers: 08-020
Study First Received: November 3, 2009
Last Updated: March 28, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
Prematurity
Inflammation
Transvaginal ultrasound
Vaginal secretion
Inflammatory process
Neonatal morbidity

Additional relevant MeSH terms:
Inflammation
Premature Birth
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 23, 2014